Board on Health Sciences Policy. June 24, 2010 Institute of Medicine The Keck Center of the National Academies 500 Fifth Street NW Room 100.

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1 INSTITUTE OF MEDICINE THE NATIONAL ACADEMIES Board on Health Sciences Policy June 24, 2010 Institute of Medicine The Keck Center of the National Academies 500 Fifth Street NW Room 100 Agenda THURSDAY JUNE 24, 2010 ROOM 100 8:00 a.m. WELCOMING REMARKS James F. Childress Chair, IOM Board on Health Sciences Policy The John Allen Hollingsworth Professor of Ethics Director, Institute for Practical Ethics and Public Life Department of Religious Studies PUBLIC ENGAGEMENT IN RESEARCH AND POLICY: A MINI-WORKSHOP Meeting Background: Public engagement efforts engage the broader society in two-way dialogues and open in-depth deliberation on important public issues and decisions, deepening the level of participation beyond efforts to educate the public and to consult with relevant institutional stakeholders. Recently, attention has been given to more fully integrating these efforts into institutional operating procedures and decision-making processes. A prominent example is President Obama s Open Government Initiative, through which all executive departments and agencies must take specific actions to implement principles of transparency, participation, and collaboration. The shift from public understanding of science toward public engagement in science is exemplified by efforts such as the Clinical and Translational Science Awards community engagement and research requirement; European Commission efforts on topics such as nanotechnology, neuroscience, and synthetic biology; and the larger role of patient organizations in funding and prioritizing disease research. Public engagement provides an opportunity for the broader society to have a role in determining the priorities emphasized in research funding, the questions asked, the issues identified around novel technologies, and the policies made on science-related issues. Participatory approaches can be seen as a means to inform policy making rather than to undertake decision making, and are complementary to specialized scientific and technical knowledge on issues where the decisions or policies involve societal values and implications as well as a scientific basis. 1

2 This topic is particularly relevant to the work of the Board on Health Sciences Policy because of its mandate to give special consideration to the ethical, legal, and social contexts of scientific and technologic advances, and to the balance between scientific opportunities and public needs. The miniworkshop will explore current efforts to engage the public in research priority setting, question development, and data interpretation and use, as well as in policy making on science-related topics, with the ultimate aim of discovering ways to more fully integrate public participation into IOM activities. Mini-Workshop Objectives: Review and discuss public engagement in research priority setting, question development, and data interpretation and use. Review and discuss public engagement in policy making on science-related issues. 8:05 a.m. OVERVIEW OF TOPIC Alan Leshner, Workshop Chair Member, IOM Board on Health Sciences Policy Chair, IOM Forum on Neuroscience and Nervous System Disorders Chief Executive Officer, AAAS Executive Publisher, Science 8:20 a.m. THE OPEN GOVERNMENT INITIATIVE 8:40 a.m. General Discussion Beth Simone Noveck Deputy Chief Technology Officer for Open Government Office of Science and Technology Policy Executive Office of the President SESSION I: PUBLIC ENGAGEMENT IN RESEARCH Panel Objectives: Review current efforts to engage the public in research priority setting, question development, and data interpretation and use. Discuss objectives and methods for engaging the public in research priority setting, question development, and data interpretation and use. 9:00 a.m. Panel Remarks Keith Norris Interim President Charles Drew University of Medicine and Science Elmer Freeman Member, NIH Director s Council on Public Representatives Executive Director, Center for Community Health Education Research and Service 2

3 Joan Scott Director, The Genetics and Public Policy Center Johns Hopkins University 9.30 a.m. General Discussion How can the public be involved in the framing of the research directions? (i.e., deciding what to do rather than deciding how to do it once it is already decided) Once you empower individuals and communities to be more involved in research, what do you do with it? For example, how do the public s views about research priorities impact the actual research and research portfolio? How do we manage the (real or perceived) tension between competitiveness in technological advancements and public participation? 9.50 a.m. BREAK SESSION II: PUBLIC ENGAGEMENT IN POLICY MAKING Panel Objectives: Review current efforts to involve the public in policy making on science-related issues. Discuss objectives and methods for involving the public upstream in the policy making process. 10:05 a.m. Panel Remarks Ruth Gaare Bernheim Director, Division of Public Health Associate Director, Institute for Practical Ethics and Public Life Ruth Wooden President Public Agenda Roger Bernier Associate Director for Science, National Immunization Program Centers for Disease Control and Prevention Rick Worthington Professor, Pomona College Board Chair, The Loka Institute Julia Joh Elligers Program Manager, National Association of County and City Health Officials 11:20 a.m. General Discussion How do you define the goal of a public engagement effort? And how do you know when you have accomplished the goal? Given the range and number of public engagement projects going on, how can we capture the results and begin to form best practices around public engagement in policy making? 3

4 SESSION III: WRAP-UP AND GENERAL DISCUSSION 12:00 p.m. Alan Leshner, Workshop Chair Member, IOM Board on Health Sciences Policy Chair, IOM Forum on Neuroscience and Nervous System Disorders Chief Executive Officer, AAAS Executive Publisher, Science GENERAL DISCUSSION How can public participation be more fully integrated into IOM activities? Are there any potential opportunities for an IOM study on public participation in research and/or science-informed policy making? 12:15 p.m. ADJOURN SESSION for LUNCH REGENERATIVE MEDICINE: A MINI-WORKSHOP ON SCIENCE AND POLICY Background: Regenerative medicine is the creation of living, functional tissues which can be used to repair or replace those that have suffered irreparable damage due to disease, age, or congenital defects. Whether this involves the in vitro growth of tissue-engineered skin or the in vivo inducement of spinal fusion with extracellular growth determinants, the field holds the promise of providing relief to those suffering from battlefield injuries to neurodegenerative diseases. Significant advances in our basic understanding of cellular growth and differentiation have driven progress in artificial organ development, tissue engineering, medical device development, and cellular therapies with significant focus coming on the future potential of stem cell biology. Even though stem cell therapies may not be ready until the far distant future, it is predicted that the field will undergo explosive growth in the next 15 years, moving from a market of $1.6 billion to $15-20 billion. This growth is predicated on near-term advancements in practical clinical applications which have the potential of significant patient benefit while simplifying the standard of care that each patient receives. With vascular regeneration therapies already in phase three clinical trials in the United States and stem cell therapy clinics widespread in China and present in countries such as Brazil and Germany, regenerative medicine is poised to make a significant impact on the health care system with a potential adjacent effect on medical device companies. However, with controversy surrounding the accuracy of reports coming from these clinics and the weak regulations in effect in China, a single serious complication attributed to the therapy could bring the entire field to a halt as it did with gene therapy. Thus, the enormous potential health and economic benefits this relatively new field could potentiate upon society must be balanced by the enactment of the proper policies and procedures to provide for patient safety. This workshop will explore the impact of regenerative medicine on patient outcomes, business models for integrating therapies into practice, and the policy issues which must be addressed to advance the field. 1:15 p.m. WELCOMING REMARKS James F. Childress Chair, IOM Board on Health Sciences Policy 4

5 The John Allen Hollingsworth Professor of Ethics Director, Institute for Practical Ethics and Public Life Department of Religious Studies 1:30 p.m. LESSONS LEARNED FROM NRC/IOM STEM CELL COMMITTEE R. Alta Charo Univ. of Wisconsin Session I: Scientific Advances and Medical Applications of Regenerative Medicine Session Objectives: To explore the current state of the science and potential medical applications of regenerative medicine. To identify existing and potential barriers to scientific and therapeutic advances. To examine the unique challenges of identifying, validating, and bringing regenerative medicine applications to market. 1:45 p.m. Panel Remarks C. Thomas Caskey Session Chair Regenerative Medicine: State of the Science Patricia Olson Executive Director of Scientific Activities California Institute for Regenerative Medicine Neuroscience and Regenerative Medicine Regina Armstrong Director, Center for Neuroscience and Regenerative Medicine Dept of Anatomy, Physiology, and Genetics Uniformed Services University of the Health Sciences Tissue Science and Engineering Christine Kelley Director, Division of Discovery Science and Technology NIBIB, NIH Commercial Aspects of Regenerative Medicine David Green President Harvard Bioscience 5

6 Advanced Treatment Options for the Severely Wounded Colonel Bob Vandre Project Director Armed Forces Institute of Regenerative Medicine (AFIRM) US Army Medical Research and Materiel Command 2:45 p.m. General Discussion How do or how could continued advances in regenerative medicine impact the general public and the scientific and health communities? Are there special issues that scientists and clinicians need to consider in the development of diagnostic and treatment paradigms? How should scientific training in regenerative medicine and engagement of the public in science be approached in light of the future implications of regenerative medicine? 3:15 p.m. BREAK Session II: Science Policy Issues Session Objective: Explore recent examples of scientific advances in the area of regenerative medicine. Discuss the potential future of the field and the associated ethical and policy implications. Identify and discuss opportunities to assist in facilitating more effective partnerships among the key stakeholders. Examine the impact that regulatory decisions have on the discovery, development, and translation of regenerative medicine therapies. Linda Giudice Session Chair 3:30 p.m. Panel Remarks Clinical Medical Ethics Bernard Lo Professor of Medicine Director, Program in Medical Ethics University of California, San Francisco Regulatory Perspective Celia M. Witten Director, Office of Cellular, Tissue and Gene Therapies Food and Drug Administration Advancements through Collaboration Susan Solomon CEO & Co-Founder The New York Stem Cell Foundation 6

7 National Policy Approaches to Advancing Regenerative Medicine Michael J. Stebbins Assistant Director for Biotechnology White House OSTP Alliance for Regenerative Medicine Michael Werner Partner Holland & Knight Human Research Considerations Jerry Menikoff Director Office of Human Research Protections 4:45 p.m. General Discussion What are the regulatory hurdles and payer concerns which might limit the ability to translate advances into practical applications? What oversight of research is needed? Are there policy gaps that hinder the advancement of regenerative medicine? Is there a need to modify current or establish new policies to ensure attention to ethical considerations? Are there areas of regenerative medicine which could be furthered by leveraging resources and sharing risks? What would be needed to produce these partnerships and what could each stakeholder bring? Are there global concerns which need to be addressed in order to safeguard the field of regenerative medicine? SESSION III: WRAP-UP AND GENERAL DISCUSSION 5:15 p.m. James F. Childress Chair, IOM Board on Health Sciences Policy The John Allen Hollingsworth Professor of Ethics Director, Institute for Practical Ethics and Public Life Department of Religious Studies 5:30 p.m. ADJOURN GENERAL DISCUSSION What role can HSP play in furthering regenerative medicine advances into practical health benefits? 7